Devices
Datascope begun an FDA-rated Class 1 recall of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) because of “System Over-Temperature” alarms that require users to power down devices to allow cooling before therapy can be reinitiated. More than 9,000 pumps are affected. The recall
Devices
AdvaMed says HHS and other federal entities can take steps that are beyond the ability and resources of the medical device industry to increase patient access to at-home use of medical technologies. Commenting on an FDA request for information on the topic, the association says the government can help
Devices
FDA has cleared an Alcresta Therapeutics 510(k) for an expanded use of ReliZorb in children ages two to five years. ReliZorb is a digestive enzyme cartridge designed to mimic the function of pancreatic lipase. It was first cleared in 2015 for use in adults, and subsequently cleared in 2017
Devices
FDA has cleared a LivaNova 510(k) for its Essenz In-Line Blood Monitor (ILBM) that provides continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures. The monitor is integrated into LivaNova’s next-generation CPB platform, the Essenz Perfusion System, which allows surgeons to access
Devices
Hamilton Medical has recalled its Hamilton-C1, C2, C3, and T1 ventilators after receiving reports about software issues that may cause the devices to stop without notice. The ventilator will switch to “Ambient State” if the device is used for more than 91 days without a restart, according to a
Devices
Responding to an FDA call for public input, the American College of Cardiology says digital health is “transforming the practice of medicine. The demand and development of medical technologies for at-home use by patients has grown exponentially and has the potential to provide great opportunities to improve outcomes, drive
Biologics
FDA has renewed its funding for the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) under a new five-year $50 million cooperative agreement. A university statement says M-CERSI is a partnership between two University of Maryland campuses and is the oldest of the
Devices
FDA has granted Quest Diagnostics a breakthrough device designation for its AAVrh74 ELISA assay, an enzyme-linked immunosorbent in vitro diagnostic for the semi-quantitative detection of antibodies (IgG) to AAVrh74 capsid in human serum. The test is intended to be used as an aid to identify patients eligible for
Devices
A 3/20-3/23 FDA inspection at Tesla BioHealing in Milford, DE, found that the company manufactures the Tesla MedBed Generator and Tesla BioHealer medical devices. An 8/10 Warning Letter says the devices are marketed with indications that they activate cellular self-repair mechanisms to treat a wide
Devices
FDA has cleared an ICU Medical 510(k) for the Plum Duo infusion pump with LifeShield infusion safety software. The device features a touch screen with a “highly intuitive user interface” and two channels capable of delivering up to four compatible intravenous medications, the company says. Its cloud-based software
Devices
Boston Scientific says it has achieved “positive 12-month results” from its pivotal ADVENT clinical trial of the FaraPulse Pulsed Field Ablation (PFA) System, a nonthermal treatment using electric fields to selectively ablate heart tissue in patients with atrial fibrillation. The study directly compared the device to standard-of-care
Devices
FDA has cleared a BioProtect 510(k) for its BioProtect Balloon Implant System, a next-generation spacer designed to provide protection to the rectum during prostate cancer radiation therapy. “We believe that our balloon has the potential to revolutionize rectal protection from toxicity during prostate cancer radiation therapy,” the company
Devices
CDRH is announcing the qualification of a new tool through the agency’s voluntary Medical Device Development Tools program: Accelerated Testing to Prove Long-Term Material Biostability. The new tool is described as a non-clinical assessment model intended to assess long-term hydrolytic biostability of thermoplastic polyurethane materials being
Devices
FDA has cleared a Fresenius Medical Care 510(k) for VersiHD with GuideMe Software, a self-guided interface for the company’s VersiHD chronic home hemodialysis (HHD) system. The device provides “graphical walk-through guidance that aims to enhance ease of use and confidence for both patients and nurses,” the
Devices
FDA says it agrees with an 8/23 Medtronic Urgent Medical Device Communication and updated patient management recommendations for its HeartWare Ventricular Assist Device (HVAD) systems. The communication describes a newly identified subgroup of HVAD pumps defined by serial numbers (subgroup 3) that have a higher risk of failure to
Devices
FDA has cleared a Paragonix Technologies 510(k) for its next-generation donor lung preservation system, BAROguard. Paragonix says the device combines its existing advanced hypothermic preservation technology with automated continuous and active airway pressure control that is intended to provide an optimal temperature range and a clinically recommended inflation
Devices
Draeger Medical has recalled (Class 1) its Carina Sub-Acute Care Ventilators due to the presence of contaminants in the devices’ airpath. “The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days,” a recall notice says, adding that testing found polyether polyurethane in the ventilator’
Devices
Rep. Debbie Dingell (D-MI) has written to FDA commissioner Robert Califf and CDC director Mandy Cohen expressing concern about an outbreak of tuberculosis (TB) linked to the implantation of contaminated bone graft material supplied by Aziyo Biologics in Silver Spring, MD. In an 8/17 letter, Dingell said a
Devices
FDA has cleared a Welldoc 510(k) for its diabetes digital health device, BlueStar, which is intended to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. The company says the BlueStar feature is being
Devices
A 5/15-5/16 FDA inspection at King Systems Corp., doing business as Ambu, Inc., in Noblesville, IN, found that the company is a manufacturer of the King LTS-D branded supraglottic airway with gastric access lumen. An 8/16 Warning Letter says the device is adulterated because Ambu
Devices
FDA has cleared a Nurami Medical 510(k) for its electrospun nanofiber-based product, ArtiFascia Dura Substitute, a resorbable dura mater repair graft. The company says neurosurgeries require replacing the dura mater, which protects the brain and cerebrospinal fluid (CSF). ArtiFascia combines two layers of electrospun nanofibers, it says, that
Devices
Unlike the regulatory requirement for nonprescription drugs that users must be able to self-diagnose, for over-the-counter medical devices FDA should recognize that the safe and effective use may not require that patients can self-diagnose the underlying medical condition. This is one of several recommendations in the